LXRP - Lexaria Provides Guidance on Upcoming R&D
(TheNewswire)
Kelowna, British Columbia - TheNewswire - February 1, 2021 –Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (C NSX :LXX. CN ) (the “Company” or“Lexaria”), a global innovator in drug delivery platforms,announces applied R&D programs to begin immediately.
Lexaria recently closed an oversubscribed financing ofUS$11 million that has greatly enhanced the Company’s ability toconduct applied R&D designed to evidence effectiveness of itspatented DehydraTECH TM drug delivery technology across multipleclasses of bioactive substances or drugs. In the weeks to come,Lexaria expects to announce many new studies designed to provideinitial evidence expected to support further study and commercialexploitation. All studies referenced within this press release arefully funded from existing Company resources.
DehydraTECH-CBD For Hypertension
Two new studies announced for the first time today areHYPER-A21-1 and HYPER-A21-2, each of which have completed theirinitial design phase and contracts have been entered with the thirdparty laboratory that will be performing the work. Animal dosing isexpected to occur in February/March with results in April/May followedby analysis and reporting when completed. In each of these studies, upto four different formulations of DehydraTECH-processed CBD will beutilized including recent enhancements intended to further optimizethe delivery of CBD in the animal test groups and measuring forperformance indicators such as rapidity and quantity of delivery tothe bloodstream and brain. Some of the formulations representGeneration 2.0 DehydraTECH improvements not yet commercially released.Additional work is expected that will also evaluate impacts uponreal-time blood pressure in animals at the doses studied.
These studies are expected to deliver additionalimportant data to Lexaria in its efforts to further support thevalidity of using DehydraTECH-processed CBD as a potentialhypertension treatment. 1.1 Billion people suffer from hypertensionwhich currently represents a US$28 billion market.
In its 2018 human clinical study, Lexaria evidencedthat DehydraTECH-processed CBD lowered human blood pressure whereasgeneric CBD did not. Since then, Lexaria has received grantedpatents in the European Union and Australia to useDehydraTECH-processed CBD to treat heart disease, and as such,investigation of DehydraTECH processed CBD as a possible treatment forhypertension will be an ongoing pursuit during 2021. Additionalplanned study work in 2021 will include a second human clinical studyin pre- and mildly-hypertensive subjects which the Company intends toinitiate after shipment of the clinical testarticles to the clinical site is completed, pending regulatoryclearances for importation as previously announced.
DehydraTECH with Antivirals forCOVID-19
In two studies first announced December 22, 2020,Lexaria will be testing four additional antiviral drugs currently inuse for various applications as detailed below. Those drugs includeremdesivir, a nucleotide reverse transcriptase inhibitor (or,“NtRTI”) and three additional drugs known to target the mainprotease associated with SARS-CoV-2 infection. The first of thesestudies VIRAL-A20-2, has completed its initial design phase, thecontract has been entered with the third party laboratory that will beperforming the work, and animal dosing is expected to occur inFebruary/March with results in May/June followed by analysis andreporting when completed. The second of these two studies(VIRAL-A20-3) is still in the initial design planning stages and theCompany will provide updates on its status as this workprogresses.
Also referenced in Lexaria’s announcement of December22, 2020 was a planned study to evaluate the relative antiviralactivity of certain DehydraTECH formulations in an effort to kill thevirus in an established cell culture model of SARS-CoV-2 infectedcells. This is study VIRAL-C21-3 and the contract is in place anddesign aspects are nearly complete with the third-party laboratorythat will be performing this work, which is expected to be underway inMarch, with results in May/June followed by analysis and reportingwhen completed. If successful, Lexaria would expect to subsequentlydesign and undertake an invivo efficacy program to determine ifDehydraTECH-enabled antiviral drug formulations offer performanceenhancement when given orally to SARS-CoV-2 infected animals.
Lexaria’s business plan relies on applied R&Dprograms to generate confirmatory results and data enabling pursuit ofcommercial opportunities and/or corporate relationships. Lexaria’sprospective business partners expect evidence that demonstratesinitial effectiveness of DehydraTECH in improving drug deliverycharacteristics, prior to entering negotiations that might includeutilization of DehydraTECH in existing or new drug classes. As such,Lexaria considers these applied R&D studies to be a vital earlystep in establishing commercial relationships with potential industrypartners to utilize DehydraTECH within their existing product lines orin the development of new product lines.
Applied R&D studies often also provide test datathat supports existing patent applications, and at times produces datathat could support additional new patent applications.
Lexaria also announces that the studies referencedwithin this press release are only a fraction of those underinvestigation or early-stage design. Additional studies in these andother fields are expected to be announced in upcoming weeks spanning arange of bioactive substances of interest to Lexaria includingantiviral drugs; CBD for hypertension; THC pharmacokinetics; nicotinein oral mucosal tissue; NSAIDs; PDE5 inhibitors; estrogen; vitamin D3;and pharmacokinetic evaluations with certain minorcannabinoids.
Lexaria Bioscience Corp.’s proprietary drug deliverytechnology, DehydraTECH™, improves the way active pharmaceuticalingredients (APIs) enter the bloodstream by promoting healthier oralingestion methods and increasing the effectiveness of fat-solubleactive molecules, thereby lowering overall dosing. The Company’stechnology can be applied to many different ingestible productformats, including foods, beverages, oral suspensions, tablets, andcapsules. DehydraTECH has repeatedly demonstrated since 2016 withcannabinoids and nicotine the ability to increase bio-absorption by upto 5-10x, reduce time of onset from 1 - 2 hours to minutes, and maskunwanted tastes; and is planned to be further evaluated for orallyadministered bioactive molecules, including anti-virals, cannabinoids,vitamins, non-steroidal anti-inflammatory drugs (NSAIDs), andnicotine. Lexaria has licensed DehydraTECH to multiple companiesincluding a world-leading tobacco producer for the development ofsmokeless, oral-based nicotine products and for use in industries thatproduce cannabinoid beverages, edibles, and oral products. Lexariaoperates a licensed in-house research laboratory and holds a robustintellectual property portfolio with 18 patents granted andapproximately 60 patents pending worldwide. For more information,please visit www.lexariabioscience.com .
CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press releaseincludes forward-looking statements. Statements as such term isdefined under applicable securities laws. These statements may beidentified by words such as "anticipate," "if,""believe," "plan," "estimate,""expect," "intend," "may,""could," "should," "will," and othersimilar expressions. Such forward-looking statements in this pressrelease include, but are not limited to, statements by the companyrelating the Company’s ability to carry out research initiatives,receive regulatory approvals or grants or experience positive effectsor results from any research or study. Such forward-looking statementsare estimates reflecting the Company's best judgment based uponcurrent information and involve a number of risks and uncertainties,and there can be no assurance that the Company will actually achievethe plans, intentions, or expectations disclosed in theseforward-looking statements. As such, you should not place unduereliance on these forward-looking statements. Factors which could cause actualresults to differ materially from those estimated by the Companyinclude, but are not limited to, government regulation and regulatoryapprovals, managing and maintaining growth, the effect of adversepublicity, litigation, competition, scientific discovery, the patentapplication and approval process, potential adverse effects arisingfrom the testing or use of products utilizing the DehydraTECHtechnology, the Company’s ability to maintain existingcollaborations and realize the benefits thereof, delays orcancellations of planned R&D that could occur related topandemics, and other factors which may be identified from time to timein the Company's public announcements and periodic filings with the USSecurities and Exchange Commission on EDGAR. There is no assurancethat any of Lexaria’s postulated uses, benefits, or advantages forthe patented and patent-pending technology will in fact be realized in any manner or in any part. No statement hereinhas been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat,cure or prevent any disease. Any forward-looking statements containedin this release speak only as of the date hereof, and the Companyexpressly disclaims any obligation to update any forward-lookingstatements contained herein, whether as a result of any newinformation, future events, changed circumstances or otherwise, exceptas otherwise required by law.
TheCSE has not reviewed and does not accept responsibility for theadequacy or accuracy of this release.
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